The following data is part of a premarket notification filed by Body Vision Medical Ltd. with the FDA for Lung Vision.
| Device ID | K163622 |
| 510k Number | K163622 |
| Device Name: | Lung Vision |
| Classification | System, Image Processing, Radiological |
| Applicant | BODY VISION MEDICAL LTD. 34 SOKOLOV ST. Ramat Hasharon, IL |
| Contact | Dorian Averbuch |
| Correspondent | Paul Dryden PROMEDIC, LLC 24301 WOODSAGE DR. Bonita Springs, FL 34134 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-22 |
| Decision Date | 2017-05-11 |
| Summary: | summary |